Cleared Traditional

Atteris No-Sting Skin Protectant (K160684) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K160684 · Rochal Industries, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
137d
Days
Class 1
Risk

K160684 is an FDA 510(k) clearance for the Atteris No-Sting Skin Protectant. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Rochal Industries, LLC (San Antonio, US). The FDA issued a Cleared decision on July 26, 2016 after a review of 137 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5090 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Rochal Industries, LLC devices

Submission Details

510(k) Number K160684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2016
Decision Date July 26, 2016
Days to Decision 137 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 115d · This submission: 137d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMF Bandage, Liquid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5090
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KMF Bandage, Liquid

All 221
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K160684.
TearRepair Liquid Skin Protectant
K241916 · Optmed, Inc. · Sep 2024
Rochal Bioshield Silicone Film
K182733 · Rochal Industries, LLC · Jun 2019
Aleo BME Liquid Bandage
K171148 · Aleo Bme, Inc. · Jan 2018
ALGISITE M
K983210 · Smith & Nephew, Inc. · Dec 1998
STING SKIN PREP WIPE(59420600)/STING SKIN PREP SWAB (59420700)
K973228 · Smith & Nephew, Inc. · Nov 1997
VIGILON PRIMARY WOUND DRESSING, STERILE
K820134 · C.R. Bard, Inc. · Feb 1982